By Kurt R. Karst – Just one day after FDA announced a December 16th public meeting and comment period to discuss the Agency’s proposed recommendations for a user fee program for biosimilar biological products for Fiscal Years (“FYs”) 2013 through 2017 (see our post here), the …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a mid-level to senior associate or counsel with substantial experience in medical device law and regulation to assist with a growing practice. Strong writing skills are required. Compensation is …
By Jennifer D. Newberger – On December 5, 2011, Senator Scott Brown (R-MA) introduced S. 1943, the “Novel Device Regulatory Relief Act of 2011.” The bill is intended to amend section 513 of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expedite the process …
By Kurt R. Karst – On December 7, 2011, FDA will publish a Federal Register notice – a prepublication version of which is available here – announcing a December 16th public meeting and comment period (Docket No. FDA-2011-N-0326) to discuss the Agency’s proposed recommendations for a …
By Ricardo Carvajal - Recent FDA actions suggest that dietary supplement firms who fail to correct deficiencies in their GMP’s do so at their peril. For example, FDA recently filed a complaint for permanent injunction against ATF Fitness Products, Inc. et al. ("ATF"), a manufacturer and …
By Riëtte van Laack – Representative Louise Slaughter (D-NY) recently sent a 4-page letter to FDA expressing her discontent with the Agency’s action (or lack thereof) related to antibiotic use in animal agriculture. Specifically, Rep. Slaughter criticizes: 1. FDA’s delay in finalizing the industry guidance #209, titled the …
By Ricardo Carvajal – FDA issued a warning letter to a food manufacturer for labeling as “all natural” a product that contains disodium dihydrogen pyrophosphate, purportedly a synthetic chemical preservative. The letter cites an alleged violation of FDC Act § 403(a)(1), under which a food is …
FDA Law Blog is pleased to announce that we’ve been selected as one of the LexisNexis Top 25 Torts Law Blogs of 2011! Here’s what the folks at LexisNexis had to say: The Top 25 group includes some of the best talent in the blogosphere and …
By Kurt R. Karst – In what appears to be the second guidance of its kind, FDA proposed in a draft bioequivalence guidance document issued earlier this week that companies seeking approval to market generic versions of RITALIN LA (methylphenidate HCl) Extended-Release Capsules must, in addition …
By Jeffrey K. Shapiro – In our continuing quest to enlighten, we are launching today an occasional series that will examine significant or interesting warning letters involving medical device companies. As you probably know, FDA issues warning letters to allege violations of the Federal Food, Drug, and …
The International Conference on Drug Development (“ICD2”), formerly known as the International Industrial Pharmacy Conference, continues its annual tradition of offering an informal forum for the exchange of ideas concerning the drug discovery and development process. The 2012 conference, which is presented by The University …
By Kurt R. Karst – Last week, the Government Accountability Office (“GAO”) released a report, titled “Food and Drug Administration: Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health,” in which the GAO examines FDA’s approaches to detecting and preventing so-called …
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Of Counsel, and former diversion investigator for the Drug Enforcement Administration (“DEA”), Larry K. Houck, explains the scope of DEA pre-registration and cyclic inspections as a step-by-step guide to actions and procedures …
By Kurt R. Karst – Almost a year after having notified Genentech of a proposal to withdraw the approval of Avastin® (bevacizumab) for use with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer, and almost five months after …
By Kurt R. Karst – Less than a month before the U.S. Supreme Court is scheduled to hear Oral Argument in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, Docket No. No. 10-844 (see here and here), concerning whether the patent delisting counterclaim provisions at FDC …
